It’s Unclear Just How Effective the Company’s COVID-19 Inoculation Will Be
It’s difficult to decide whether to be more suspicious of the Trump administration or the major drugmakers when evaluating the coming COVID-19 vaccine rollout.
The administration, eager to take credit for the unusually quick development of at least two products, is now revealed to have passed up the opportunity to lock in larger supplies of the Pfizer offering. That prompted the company to make deals with other countries. Trump tried to cover up the error with an America First executive order, but that action is said to be unenforceable.
Unless some of the other vaccines in development come to fruition soon, it may take a lot longer than promised to inoculate the U.S. population. The situation is worsened by the decision of the administration to leave states to work out distribution plans on their own.
The combination of Trump administration incompetence and the questionable track record of companies like AstraZeneca and Pfizer is giving ammunition to vaccine skeptics.
Pfizer, meanwhile, was getting showered with praise as its vaccine began to be administered in the United Kingdom, yet it soon had to contend with reports of several serious allergic reactions. The company, it turns out, had excluded people with a history of significant adverse reactions to vaccines from late-stage trials. UK officials are now telling those with serious allergies to put off getting the shot.
Then there is AstraZeneca, whose vaccine developed with the University of Oxford appears to be effective. Exactly how effective is in doubt given that researchers initially screwed up the doses given during the clinical trial and had to improvise.
Back in September, AstraZeneca had to halt the clinical trial after a participant fell ill. The company apparently infuriated the Food and Drug Administration by failing to warn it about the problem before the story became public. The New York Times called the incident “part of a pattern of communication blunders by AstraZeneca that has damaged the company’s relationship with regulators, [and] raised doubts about whether its vaccine will stand up to intense public and scientific scrutiny.”
AstraZeneca’s shortcomings did not start with its COVID-19 project. Like Pfizer, AstraZeneca has been accused of engaging in illegal marketing. In 2010 it paid $520 million to the U.S. Justice Department to resolve allegations that it promoted its anti-psychotic drug Seroquel for uses not approved as safe and effective by the FDA. Among other things, the company was accused of having paid doctors to give speeches and publish articles ghostwritten by the company promoting those unapproved uses.
The company also has been embroiled in controversies about overpricing. In 2007 a federal judge ruled in a national class-action case that AstraZeneca and two other companies had to pay damages in connection with overcharging Medicare and private insurance companies. The judge singled out AstraZeneca for acting “unfairly and deceptively” in its pricing of the prostate cancer drug Zoladex. The company was later hit with a $12.9 million judgment.
The combination of Trump administration incompetence and the questionable track record of companies like AstraZeneca and Pfizer is giving ammunition to vaccine skeptics. We only can hope the FDA review process makes a convincing case for the safety of the vaccines and that the new Biden administration shows greater skill in working out the details for their distribution.